Journal/Magazine Articles

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This collection contains original research articles, review articles and case reports published in local and international peer reviewed journals by the staff members of the Faculty of Medicine

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Author: search.filters.author.de Silva, A.

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    Rationale for a new low-dose triple single pill combination for the treatment of hypertension
    (Elsevier, 2024) Rodgers, A.; Salam, A.; Cushman, W.; de Silva, A.; Tanna, G.L.D.; Gnanenthiran, S.R.; Grobbee, D.; Narkiewicz, K.; Ojji, D.; Oparil, S.; Poulter, N.; Schlaich, M.P.; Schutte, A.E.; Spiering, W.; Williams, B.; Wright, J.T.Jr.; Whelton, P.
    Two recent large trials showed the potential of single pill combinations (SPCs) with ≥3 low-dose components among people with hypertension who were untreated or receiving monotherapy. In both trials, these 'hypertension polypills' were superior to usual care, achieving >80% BP control without increasing withdrawal due to side effects. However, there are no such products available for prescribers. To address this unmet need, George Medicines developed GMRx2 with telmisartan/amlodipine/indapamide in three strengths (mg): 10/1.25/0.625, 20/2.5/1.25; 40/5/2.5. Two pivotal trials are ongoing to support FDA submission for the treatment of hypertension, including initial treatment. These assess efficacy and safety of GMRx2 compared to: placebo, and each of the three possible dual combinations. Regulatory submissions are planned for 2024, with the aim of providing access to GMRx2 in developed and developing regions. Wider implementation of GMRx2-based treatment strategies will be guided by further research to inform access and appropriate scale up.
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    Duplication errors due to brand name confusion; It is not always the name-Short case series
    (John Wiley & Sons, 2023) Mamunuwa, N.; Jayamanne, S.; Wijekoon, N.; Coombes, J.; Perera, D.; Shanika, T.; Mohamed, F.; Lynch, C.; de Silva, A.; Dawson, A.
    Confusion of drug names has been identified as a leading cause of medication errors and potential iatrogenic harm. Most of these errors occur because of look-alike or sound-alike drugs. This case series gives examples of duplication errors due to brand confusion, where there are no similarities in the names.
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    The third intensive care bundle with blood pressure reduction in acute cerebral haemorrhage trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial
    (Elsevier, 2023) Ma, L.; Hu, X.; Song, L.; Chen, X.; Ouyang, M.; Billot, L.; Li, Q.; Malavera, A.; Li, X.; Muñoz-Venturelli, P.; de Silva, A.; Thang, N.H.; Wahab, K.W.; Pandian, J.D.; Wasay, M.; Pontes-Neto, O.M.; Abanto, C.; Arauz, A.; Shi, H.; Tang, G.; Zhu, S.; She, X.; Liu, L.; Sakamoto, Y.; You, S.; Han, Q.; Crutzen, B.; Cheung, E.; Li, Y.; Wang, X.; Chen, C.; Liu, F.; Zhao, Y.; Li, H.; Liu, Y.; Jiang, Y.; Chen, L.; Wu, B.; Liu, M.; Xu, J.; You, C.; Anderson, C.S.; INTERACT3 Investigators
    BACKGROUND: Early control of elevated blood pressure is the most promising treatment for acute intracerebral haemorrhage. We aimed to establish whether implementing a goal-directed care bundle incorporating protocols for early intensive blood pressure lowering and management algorithms for hyperglycaemia, pyrexia, and abnormal anticoagulation, implemented in a hospital setting, could improve outcomes for patients with acute spontaneous intracerebral haemorrhage. METHODS: We performed a pragmatic, international, multicentre, blinded endpoint, stepped wedge cluster randomised controlled trial at hospitals in nine low-income and middle-income countries (Brazil, China, India, Mexico, Nigeria, Pakistan, Peru, Sri Lanka, and Viet Nam) and one high-income country (Chile). Hospitals were eligible if they had no or inconsistent relevant, disease-specific protocols, and were willing to implement the care bundle to consecutive patients (aged ≥18 years) with imaging-confirmed spontaneous intracerebral haemorrhage presenting within 6 h of the onset of symptoms, had a local champion, and could provide the required study data. Hospitals were centrally randomly allocated using permuted blocks to three sequences of implementation, stratified by country and the projected number of patients to be recruited over the 12 months of the study period. These sequences had four periods that dictated the order in which the hospitals were to switch from the control usual care procedure to the intervention implementation of the care bundle procedure to different clusters of patients in a stepped manner. To avoid contamination, details of the intervention, sequence, and allocation periods were concealed from sites until they had completed the usual care control periods. The care bundle protocol included the early intensive lowering of systolic blood pressure (target <140 mm Hg), strict glucose control (target 6·1-7·8 mmol/L in those without diabetes and 7·8-10·0 mmol/L in those with diabetes), antipyrexia treatment (target body temperature ≤37·5°C), and rapid reversal of warfarin-related anticoagulation (target international normalised ratio <1·5) within 1 h of treatment, in patients where these variables were abnormal. Analyses were performed according to a modified intention-to-treat population with available outcome data (ie, excluding sites that withdrew during the study). The primary outcome was functional recovery, measured with the modified Rankin scale (mRS; range 0 [no symptoms] to 6 [death]) at 6 months by masked research staff, analysed using proportional ordinal logistic regression to assess the distribution in scores on the mRS, with adjustments for cluster (hospital site), group assignment of cluster per period, and time (6-month periods from Dec 12, 2017). This trial is registered at Clinicaltrials.gov (NCT03209258) and the Chinese Clinical Trial Registry (ChiCTR-IOC-17011787) and is completed. FINDINGS: Between May 27, 2017, and July 8, 2021, 206 hospitals were assessed for eligibility, of which 144 hospitals in ten countries agreed to join and were randomly assigned in the trial, but 22 hospitals withdrew before starting to enrol patients and another hospital was withdrawn and their data on enrolled patients was deleted because regulatory approval was not obtained. Between Dec 12, 2017, and Dec 31, 2021, 10 857 patients were screened but 3821 were excluded. Overall, the modified intention-to-treat population included 7036 patients enrolled at 121 hospitals, with 3221 assigned to the care bundle group and 3815 to the usual care group, with primary outcome data available in 2892 patients in the care bundle group and 3363 patients in the usual care group. The likelihood of a poor functional outcome was lower in the care bundle group (common odds ratio 0·86; 95% CI 0·76-0·97; p=0·015). The favourable shift in mRS scores in the care bundle group was generally consistent across a range of sensitivity analyses that included additional adjustments for country and patient variables (0·84; 0·73-0·97; p=0·017), and with different approaches to the use of multiple imputations for missing data. Patients in the care bundle group had fewer serious adverse events than those in the usual care group (16·0% vs 20·1%; p=0·0098). INTERPRETATION: Implementation of a care bundle protocol for intensive blood pressure lowering and other management algorithms for physiological control within several hours of the onset of symptoms resulted in improved functional outcome for patients with acute intracerebral haemorrhage. Hospitals should incorporate this approach into clinical practice as part of active management for this serious condition. FUNDING: Joint Global Health Trials scheme from the Department of Health and Social Care, the Foreign, Commonwealth & Development Office, and the Medical Research Council and Wellcome Trust; West China Hospital; the National Health and Medical Research Council of Australia; Sichuan Credit Pharmaceutic and Takeda China.
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    Efficacy and safety of low-dose triple and quadruple combination pills vs monotherapy, usual care, or placebo for the initial management of hypertension: A systematic review and meta-analysis
    (American Medical Association, 2023) Wang, N.; Rueter, P.; Atkins, E.; Webster, R.; Huffman, M.; de Silva, A.; Chow, C.; Patel, A.; Rodgers, A.
    IMPORTANCE: Low-dose combination (LDC) antihypertensives consisting of 3 or 4 blood pressure (BP)-lowering drugs have emerged as a potentially important therapy for the initial management of hypertension. OBJECTIVE: To assess the efficacy and safety of LDC therapies for the management of hypertension. DATA SOURCES: PubMed and Medline were searched from date of inception until September 2022. STUDY SELECTION: Randomized clinical trials comparing LDC consisting of 3 or 4 BP-lowering drugs compared to either monotherapy, usual care, or placebo. DATA EXTRACTION AND SYNTHESIS: Data were extracted by 2 independent authors and synthesized using both random and fixed-effects models using risk ratios (RR) for binary outcomes and mean differences for continuous outcomes. MAIN OUTCOMES AND MEASURES: The primary outcome was mean reduction in systolic BP (SBP) between LDC and monotherapy, usual care, or placebo. Other outcomes of interest included the proportion of patients achieving BP less than 140/90 mm Hg, rates of adverse effects, and treatment withdrawal. RESULTS: Seven trials with a total of 1918 patients (mean [mean range] age, 59 [50-70] years; 739 [38%] female) were included. Four trials involved triple-component LDC and 3 involved quadruple-component LDC. At 4 to 12 weeks follow-up, LDC was associated with a greater mean reduction in SBP than initial monotherapy or usual care (mean reduction, 7.4 mm Hg; 95% CI, 4.3-10.5) and placebo (mean reduction, 18.0 mm Hg; 95% CI, 15.1-20.8). LDC was associated with a higher proportion of participants achieving BP less than 140/90 mm Hg at 4 to 12 weeks compared to both monotherapy or usual care (66% vs 46%; RR, 1.40; 95% CI, 1.27-1.52) and placebo (54% vs 18%; RR, 3.03; 95% CI, 1.93-4.77). There was no significant heterogeneity between trials enrolling patients with and without baseline BP-lowering therapy. Results from 2 trials indicated LDC remained superior to monotherapy or usual care at 6 to 12 months. LDC was associated with more dizziness (14% vs 11%; RR 1.28, 95% CI 1.00-1.63) but no other adverse effects nor treatment withdrawal. CONCLUSIONS AND RELEVANCE: The findings in the study showed that LDCs with 3 or 4 antihypertensives were an effective and well-tolerated BP-lowering treatment option for the initial or early management of hypertension.
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    Reduced efficacy of blood pressure lowering drugs in the presence of diabetes mellitus-results from the TRIUMPH randomised controlled trial
    (Nature Publishing Group, 2023) Gnanenthiran, S.R.; Webster, R.; de Silva, A.; Maulik, P.K.; Salam, A.; Selak, V.; Guggilla, R.K.; Schutte, A.E.; Patel, A.; Rodgers, A.; TRIUMPH Study Group
    We investigated whether diabetes mellitus (DM) affects the efficacy of a low-dose triple combination pill and usual care among people with mild-moderate hypertension. TRIUMPH (TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension) was a randomised controlled open-label trial of patients requiring initiation or escalation of antihypertensive therapy. Patients were randomised to a once-daily low-dose triple combination polypill (telmisartan-20mg/amlodipine-2.5 mg/chlorthalidone-12.5 mg) or usual care. This analysis compared BP reduction in people with and without DM, both in the intervention and control groups over 24-week follow-up. Predicted efficacy of prescribed therapy was calculated (estimation methods of Law et al.). The trial randomised 700 patients (56 ± 11 yrs, 31% DM). There was no difference in the number of drugs prescribed or predicted efficacy of therapy between people with DM and without DM. However, the observed BP reduction from baseline to week 24 was lower in those with DM compared to non-diabetics in both the triple pill (25/11 vs 31/15 mmHg, p ≤ 0.01) and usual care (17/7 vs 22/11 mmHg, p ≤ 0.01) groups, and these differences remained after multivariable adjustment. DM was a negative predictor of change in BP (β-coefficient -0.08, p = 0.02). In conclusion, patients with DM experienced reduced efficacy of BP lowering therapies as compared to patients without DM, irrespective of the type of BP lowering therapy received.
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    Recurrent vaginal vault dehiscence and evisceration following total laparoscopic hysterectomy, successfully repaired with polypropylene mesh and sacrocolpopexy
    (Oxford University Press, 2022) Rathigashini, R.; Wanniarachchi, W.A.D.P.; de Silva, A.; Herath, R.P.
    Recurrent vault dehiscence is a rare and potentially serious complication following hysterectomy. We report a rare case of recurrent vault dehiscence and evisceration following a total laparoscopic hysterectomy (TLH) which was successfully repaired with polypropylene mesh and sacro-colpopexy. A 47-year-old multiparous woman underwent TLH for adenomyosis. During the surgery, vaginal wall was incised with monopolar diathermy and sutured with synthetic absorbable barbed suture in a single layer. She presented 12 weeks later with vault dehiscence and evisceration of omentum. Laparoscopically, eviscerated omental part was removed and the vaginal cuff was repaired vaginally with absorbable synthetic suture. She came with a recurrence in 3 months with vault dehiscence and a vault prolapse without any evisceration. She underwent laparoscopic mesh repair of the vault combined with laparoscopic Sacro-colpopexy with complete recovery. Incidence of vault dehiscence is found to be higher in TLH than abdominal or vaginal hysterectomy. Treatment options for recurrent vault dehiscence involve strengthening the vault with tissues, or with a prosthesis.
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    Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes: A Randomized Clinical Trial
    (American Medical Association, 2022) Tandon, N.; Gupta, Y.; Kapoor, D.; Lakshmi, J.K.; Praveen, D.; Bhattacharya, A.; Billot, L.; Naheed, A.; de Silva, A.; Gupta, I.; Farzana, N.; John, R.; Ajanthan, S.; Divakar, H.; Bhatla, N.; Desai, A.; Pathmeswaran, A.; Prabhakaran, D.; Joshi, R.; Jan, S.; Teede, H.; Zoungas, S.; Patel, A.; LIVING Collaborative Group.
    Importance: Women with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes. Objective: To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia. Design, setting, and participants: This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021. Interventions: A 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care. Main outcomes and measures: The primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight. Results: A total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome. Conclusions and relevance: This study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals.
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    INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial
    (BioMed Central, London, 2021) Song, L.; Hu, X.; Ma, L.; Chen, X.; Ouyang, M.; Billot, L.; Li, Q.; Muñoz-Venturelli, P.; Abanto, C.; Pontes-Neto, O.M.; Antonio, A.; Wasay, M.; de Silva, A.; Thang, N.H.; Pandian, J.D.; Wahab, K.W.; You, C.; Anderson, C.S.
    Background: Early intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the treatment effects by approach to control BP. As the third in a series of clinical trials on this topic, the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) aims to determine the effectiveness of a goal-directed care bundle protocol of early physiological control (intensive BP lowering, glycemic control, and pyrexia treatment) and reversal of anticoagulation, in acute ICH. Methods: INTERACT3 is a pragmatic, international, multicenter, stepped-wedge (4 phases/3 steps), cluster-randomized controlled trial to determine the effectiveness of a multifaceted care package in adult (age ≥ 18 years) patients (target 8360) with acute ICH (< 6 h of onset) recruited from 110 hospitals (average of 19 consecutive patients per phase) in low- and middle-income countries. After a control phase, each hospital implements the intervention (intensive BP lowering, target systolic < 140 mmHg; glucose control, target 6.1-7.8 mmol/L and 7.8-10.0 mmol/L in those without and with diabetes mellitus, respectively; anti-pyrexia treatment to target body temperature ≤ 37.5 °C; and reversal of anticoagulation, target international normalized ratio < 1.5 within 1 h). Information will be obtained on demographic and baseline clinical characteristics, in-hospital management, and 7-day outcomes. Central trained blinded assessors will conduct telephone interviews to assess physical function and health-related quality of life at 6 months. The primary outcome is the modified Rankin scale (mRS) at 6 months analyzed using ordinal logistic regression. The sample size of 8360 subjects provides 90% power (α = 0.05) to detect a 5.6% absolute improvement (shift) in the primary outcome of the intervention versus control standard care, with various assumptions. Discussion: As the largest clinical trial in acute ICH, INTERACT3 is on schedule to provide an assessment of the effectiveness of a widely applicable goal-directed care bundle for a serious condition in which a clearly proven treatment has yet to be established.
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    Possible progression of an atypical leiomyoma to a leiomyosarcoma: a case report
    (Menopause Society of Sri Lanka, 2021) Ekanayake, C.D.; Herath, R.; Fernando, S.; Mahendra, G.; Balawardene, J.; de Silva, A.
    The spectrum of uterine smooth muscle cell tumours (SMT) ranges from leiomyomas to leiomyosarcomas (LMS). Atypical leiomyomas (AL) are a uterine SMT of a contentious nature due to its indeterminate malignant potential. Although the risk of recurrence is low there is limited experience on management. On the other hand, it is generally believed that the uterine LMS arises de novo, rather than from a precursor lesion.
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    The use of personal protective equipment in endoscopy: what should the endoscopist wear during a pandemic?
    (Taylor & Francis, 2021) Jayasena, H.; Abeynayake, D.; Niriella, M.; de Silva, H.J.; de Silva, A.
    Endoscopists are at high risk of exposure and nosocomial transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus) when performing endoscopic procedures due to the highly aerosol generating nature of these procedures. At present, there is still no consensus among endoscopists with regards to the type of protective equipment to be worn by healthcare workers, when performing endoscopy during the coronavirus 2019 (COVID-19) pandemic. This review encompasses a summary of currently published guidelines related to the use of personal protective equipment (PPE) when performing endoscopic procedures during the COVID-19 pandemic. With increasing calls to rationalize the use of PPE due to shortages in global supply chains, the review offers a concise summary on the most appropriate and adequate use of PPE when performing endoscopy during the pandemic. It is expected that these adaptations in the use of PPE during the pandemic will help to improve standards of care and safety of healthcare workers.